Transient Loss of Consciousness / Syncope Fainting
Conditions
Interventions
If a tilt-table test will be performed this will entail the following:After 10 minutes of lying down the tilt table will be tilted to an angle of 70 degrees, you will be kept in this position for 10 m
Sponsors
Amsterdam UMC
Eligibility
Age
16 Years to 64 Years
Inclusion criteria
Inclusion criteria: All patients >18 years of age with certain/highly likely vasovagal syncope after the guideline based syncope evaluation on the syncope outpatient clinic
Exclusion criteria
Exclusion criteria: Those aged <18 yearsAny patient diagnosed with another form of reflex syncope other than vasovagal syncopeContraindication for tilt table testing at the discretion of the responsible physician Those with a learning disabilityThose presenting with pre-syncope and not with complete loss of consciousnessThose who are unwilling to provide informed consentThose already diagnosed prior to evaluation who are referred for specific treatment options. Those who have severe autonomic syncope, defined as patients with at least one of the following: -Frequent episodes, to the discretion of the physician (as the broad spectrum of severity of syncope and frequency is not definable in a specific number)-Restriction of educational or occupational activities (including, but not limited to, unemployment) -Restriction of social or daily-life activities, e.g. when syncope occurs while driving
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints:Time to first syncope | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpointsQuality of lifeEconomic evaluationQuality of life and patient perspectiveAll patients will be asked to fill out questionnaires upon enrollment and after 3, 6, 9 and 12 months of follow up (for details regarding filling out, see section 6.5).Baseline quality of life measurements will be conducted upon enrollment. For the quality of life assessment the EQ-5D-5L, Short form-12 (SF-12), Syncope Functional Status Questionnaire (SDF) will be filled out (for details regarding filling out, see section 6.5). For the patient perspective a set of general questions by the study team, the Utrecht coping questionnaires and Consumer Quality (CQ) index questionnaires will be used (for details regarding the frequency of filling out during follow up, see section 6.5).Economic evaluation/ Health Care costsHealth care costs will be calculated on the basis of the tariffs set by the schedule of the Dutch National Health Service. The average cost price for a consult with tilt table testing (reference treatment strategy) and average cost price for a consult without tilt table testing (investigational treatment strategy) will be applied for calculation of the costs.All health care costs will be evaluated/included in both management strategies whether these are related to syncope or not. Syncope-related costs are defined as all tests, admissions and consultations that relate to syncope (e.g. extra outpatient clinic consults, holter ECG, echo, tilt table test, etc.). Only those tests mentioned in the ESC/EHRA guidelines will be included. In addition, all tests, admissions and consultations related to injuries due to syncope (e.g. head trauma, hip fracture) will be added to the syncope-related costs. For the economic evaluation, patients will be asked to complete the iMCQ and iPCQ tailored for the trial with respect to the diagnosis vasovagal syncope (for details regarding filling out, see section 6.5). | — |
Countries
Netherlands
Contacts
Public ContactT.T. Boel
Amsterdam UMC
Outcome results
None listed